11/08/2012 - ATIN - In a major disappointment to those closely watching clinical trials for the effectiveness of a compound called vigabatrin in combating addiction and its potential uses in addiction treatment drug rehab and alcohol rehab, Catalyst Pharmaceuticals Partners announced its targeted cocaine addiction treatment, CPP-109, didn't meet the primary endpoint of a Phase ll(b) study. The company said treatment didn't result in a significant amount of cocaine-free subjects during the length of the study, as well as not meeting secondary endpoints of fewer negative urine tests or fewer cocaine-free days by subjects during the study period.

Major Disappointment

The news is a big-time set back for those in the addiction research scientific community who had high hopes for vigabatrin, as well as for investors. Catalyst (NASADAQ: CPRX) is one of the oldest of a growing number of "pure play" addiction biopharmas that have been listed on various exchanges worldwide. Investors had bid the company's shares up by 12 percent this year in anticipation of positive clinical trial results, but yesterday they dumped shares on more than 20 times average share trading volume resulting in a 65 percent drop in the value of the stock.

$600M Opportunity?

Some analysts, working off Reckitt Benckiser's more than $1BN annual sales blockbuster drug Suboxone, had scaled a successful cocaine/methamphetamine solution by Catalyst to be worth potentially $600M in annual sales. There are more than three dozen compounds in addiction focused clinical development by commercial drug makers, a record, and many more are in the planning stages, spurred especially by the huge profits generated by Suboxone. A drag on development, to some extent, has been the abject failure after many years of Alkermes to generate any significant sales of its massively overpriced VIVITROL even after blowing through $250M in marketing expenses in the early years following FDA approval. And Catalyst's bad news certainly will not help when it comes to encouraging commercial drug companies to fund research into addictions solutions. It joins a long list of disappointments, including Somoxon's nalmafene and Terren's Peizer's huge $140M flop with Hythiam.

Big NIDA Money

Particularly disappointed will be those scientists at NIDA and Veterans Affairs who had been so impressed with vigabatrin that they backed much of the cost of Catalyst's recent failed study, to the tune of $11M. The degree to which Catalyst had to rely on government funding for the trial is an indicator of the reluctance of private investors to fund highly risky addictions drug R&D.

read our look at Catalyst's CEO Patrick McEnany in our Special Report "Addiction's Biopharmas"

read our Special Report "The Physiological Frontier"

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